Temperature Study in Cesarean Section

Study Using Fluid Warming and Forced Air Warming Immediately Prior to and During Elective Cesarean Section

During surgery body temperature can decrease which can adversely affect how people recover from surgery. This is a common problem. We aim to reduce the incidence of this drop in body temperature during surgery by testing the effectiveness of warm intravenous fluids that the patients will receive as they are being infused, and of warm air blown into a blanket covering the body. The control group will not have any active warming methods.

Study group 1 will have the intravenous fluid warmer in the pre- and intraoperative period. Study group 2 will have a forced-air warmer in the intra-operative period as well as the fluid warmer in the pre- and intraoperative period. We will also observe the neonates' vital signs following delivery.

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Hypothermia
• Intervention / Treatment: Other: Warmed fluids; Device: Belmont fluid warmer; Other: Fluid warmer and warming blanket; Device: Bair hugger warming blanket

Detailed Description

Potential participants will be approached by a member of the research team prior to surgery.

Patients will be fully informed of the study by a study investigator, full written informed consent will be obtained. We will recruit healthy ASA 1 and 2 patients undergoing uncomplicated elective cesarean sections. Patients will be randomised into one of three groups.

Control group will have no active warming. Study group 1 will have pre- and intraoperative intravenous fluid warming. Study group 2 will have the same as study group 1 but with additional intraoperative warming air blown into a blanket covering the body.

Temperature measurements will be taken in the pre-op holding area prior to intravenous fluid administration, and thereafter at 15-minute intervals until one hour post-surgery.

At the same time as temperature monitoring the patients will be assessed for shivering (4 point scale) and will be asked their comfort level with regard to their temperature (5 point scale).

We will record vital signs (measured routinely by the pediatricians at cesarean delivery) from the neonate immediately following delivery. Samples of blood will be taken from the placental cord following delivery to measure cord blood gas results.

We will carry out a chart review looking at the success rate of breast feeding (if applicable).

• We are studying the effect of intravenous fluid warming and forced-air warming on your body temperature at the time of your cesarean section.
• Perioperative hypothermia can have adverse affects on your health and recovery following surgery so the aim of this study is to find ways to prevent or reduce the incidence of hypothermia.
• Participants will be randomized into one of three groups. The control group will not receive any perioperative warming. Study group 1 will have intravenous fluids warmed. Study group 2 will be the same as group 1 with the addition of a forced-air warmer in the operating room. Your temperature will be taken in the pre-op holding area prior to intravenous fluid administration, and thereafter at 15-minute intervals until one hour post-surgery. At the time of the temperature measurements we will also assess any shivering you may have and also question you regarding how warm/cold you feel.
• Following delivery of the placenta we will send one blood sample taken from the placental cord to the biochemistry laboratory for analysis of the cord blood gases. The blood sample will not be stored for future studies.
• We will be observing the vital signs of the neonate immediately following delivery.
• We will be carrying out a chart review looking at the success rate of breast feeding (if applicable).

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:18-40 years. Healthy term (> 37 weeks) pregnant patients undergoing elective cesarean section with spinal anesthesia.

We will not discriminate with regard to ethnic background. ASA 1 and 2 patients scheduled for elective cesarean sections under spinal anesthesia at LPCH.

Exclusion Criteria:Not ASA 1 or 2 Not spinal anesthetic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; No peri-operative warming.
EXPERIMENTAL: Warmed fluids; Patients will receive warmed i.v. fluids administered pre- and intra-operatively.	Other: Warmed fluids; IV fluids warmed by a Belmont fluid warmer; Device: Belmont fluid warmer; Belmont fluid warmer used to warm fluids
EXPERIMENTAL: Warmed fluids and warm air; Patients will receive warmed i.v. fluids administered pre- and intra-operatively, and warmed air blown into a blanket covering the body intra-operatively.	Other: Warmed fluids; IV fluids warmed by a Belmont fluid warmer; Device: Belmont fluid warmer; Belmont fluid warmer used to warm fluids; Other: Fluid warmer and warming blanket; Warm are blown into a Bair hugger warming blanket covering the patient; Device: Bair hugger warming blanket; Bair hugger warming blanket laid on body

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
temperature	measured every 15 minutes from spinal anesthetic administration	immediately prior to surgery upto 3hours post spinal anesthetic

Secondary Outcome Measures

Outcome Measure	Time Frame
Fetal pH	Post partum

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Study Director: Edward Riley, Stanford University; Sub-Investigator: Gill Hilton, Stanford University; Principal Investigator: Pervez Sultan, Stanford University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2013
• Primary Completion (ACTUAL): April 30, 2015
• Study Completion (ACTUAL): April 30, 2015

Study Registration Dates

• First Submitted: November 23, 2010
• First Submitted That Met QC Criteria: November 24, 2010
• First Posted (ESTIMATE): November 25, 2010

Study Record Updates

• Last Update Posted (ACTUAL): June 8, 2018
• Last Update Submitted That Met QC Criteria: June 6, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: SU-11102010-7189

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No